Oxaprozin

ANDA 75847, held by Mylan Pharms Inc. Oxaprozin.

As of Nov 13, 2026, ANDA 75847 (Oxaprozin), held by Mylan Pharms Inc, was first approved by FDA on Feb 28, 2001, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 28, 2001
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 28, 2001	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxaprozin600MG · tablet;oral	Oxaprozin	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 29, 2002	Supplement 1Manufacturing	Approved	None posted
Feb 28, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75847
Drugs@FDA: Overview at FDA
Company: Mylan Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters